Regulatory Affairs Consulting

The American College of Regenerative Medicine offers assistance with your Phase I, II and III clinical trial submissions. We are able to function as your Head of Regulatory Affairs to prepare and submit Investigational New Drug (IND) applications to the FDA.

With years of IND filing experience our experts can participate in meetings with the FDA and guide the acquisition of pertinent information required for IND submission, including necessary preclinical data and manufacturing information – a critical step in the application and approval process.

Regulatory filings and agency interactions include the following:

  • Creating Meeting Requests

  • Authoring Briefing Documents

  • Meeting Preparation

  • Agency Meeting Participation

  • Meeting Follow-Up

  • Meeting Minutes

  • Agency Feedback Assessment

  • Follow-Up Strategies

  • Protocol Amendment

  • PI Change, Addition and Removal

  • Annual Report

  • Investigator Brochures

  • FDA Adverse Event Reporting

  • FDA Serious Adverse Event Reporting

  • Regulatory Project Management

  • Regulatory Activity SOP Development

  • FDA & EU Remediation (483 Observations, Warning Letters, Consent Decrees)


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